Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Remarks:

intraperitoneal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

5 male and 5 female NMRI mice are administered 700 mg/kg bw test item by a single intraperitoneal injection to the abdominal cavity. The solution comprises 7 % suspension of the test item in 0.5 % aqueous Carboxymethyl cellulose (CMC). Test animals are monitored for mortality and toxic symptoms for 14 days and surviving animals are subjected to gross pathology analysis at necropsy.

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate

EC Number:

216-760-3

EC Name:

Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate

Cas Number:

1658-56-6

Molecular formula:

C20H13N2NaO4S

IUPAC Name:

NA

Test material form:

solid: particulate/powder

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Versuchstierzucht WIGA, Sulzfeld, DE
- Weight at study initiation: males: 24.0 g (mean); females: 22.0 g (mean)
- Fasting period before study: 16 hours
- Diet: ad libitum; Herilan MRH-Kraftfutter (H. Eggersmann, Rinteln/Weser, DE)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- not specified

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

CMC (carboxymethyl cellulose)

Details on exposure:

An aqueous solution of 7 % test item suspended in 0.5 % carboxylmethyl cellulose was administered to each animal by intraperitoneal injection to the abdominal cavity.

Doses:

All animals were administered 700 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 24 and 48 hours and 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality and toxic symptoms

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 700 mg/kg bw

Based on:

test mat.

Mortality:

1 hour: no mortality was observed
24 hours: no mortality was observed
48 hours: 3 male and 2 female animals died
7 days: no further mortality was observed
14 days: no further mortality was observed

Clinical signs:

Clinical signs were nonspecific

Gross pathology:

Dead animals: no intra-abdominal test item precipitation or lesions
Sacrificed animals: no intra-abdominal test item precipitation or lesions

Any other information on results incl. tables

Table 1: mortality of test animals administered test item by intraperitoneal injection to the abdominal cavity

Dose (mg/kg bw)	Concentration (%)	Gender	No. animals	Number of animals found dead within:
				1 hour	24 hours	48 hours	7 days	14 days
700	7	male	5	0	0	3	3	3
700	7	female	5	0	0	2	2	2

Applicant's summary and conclusion

Conclusions:

LD50 (intraperitoneal injection, mouse) was found to be approximately 700 mg/kg bw.

Executive summary:

The acute toxicity of the test item by intraperitoneal injection was evaluated in an experimental study in a limit test without controls. 7 % test item suspended in an aqueous solution of 0.5 % carboxymethyl cellulose was administered to 5 male and 5 female NMRI mice at a concentration of 700 mg/kg bw test item by intraperitoneal injection to the abdominal cavity. Mortality and toxic symptoms were observed at 1, 24 and 48 hours and 7 and 14 days after administration and all animals were subjected to gross pathology analysis at necropsy.

After 1 and 24 hours, no mortality was observed. After 48 hours, 3 male and 2 female animals were found dead. No further mortality occurred within the 14-day study period. Unspecific toxic symptoms observed during the study period. No intra-abdominal test item precipitation or lesions were observed in any test animals at necropsy. The LD50 of the test item was estimated to be approximately 700 mg/kg bw in rats following intraperitoneal injection.